FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?
    Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?

    The explosion of gene therapy candidates in clinical development is being led by a diverse set of originators, including many hospital and university labs. While these are great incubators for innovation, the many small labs working in isolation do not have experience in commercializing a medicine for wide and sustained use in patients, and this could slow the acceptance of gene therapies for the people who really need them. Health authorities have recognized the importance of getting gene therapies into standard use and are supporting doing so with accelerated pathways.

  • Improving Training In Biopharmaceutical Manufacturing
    Improving Training In Biopharmaceutical Manufacturing

    Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.

  • 5 Strategies To Combat Counterfeit Drugs And Pharma Supply Chain Threats
    5 Strategies To Combat Counterfeit Drugs And Pharma Supply Chain Threats

    Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.

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PHARMA OUTSOURCING WHITE PAPERS

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

Managing Demand Uncertainty In Biologics Production

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

BioProcess Containers – Materials Of Construction

Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).

Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Collaboration With Third Parties And Its Impact On Document Management

Collaboration takes many forms; this article will look at how document production, distribution and archiving are affected by the virtual pharma model and in clinical and manufacturing quality settings.

Phase II Alzheimer's Case Study

A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.

The Environmental Impact of Clinical Trials

For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.

Quality Trumps Cost With Clinical Logistics Providers

Part two of Marken CEO Wes Wheeler’s ten part blog series about the changing face of Life Science Logistics in today’s fast-paced pharmaceutical industry. By Wes Wheeler, Marken

 

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

  • Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities
    Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities

    By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.

  • Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?
    Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?

    As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.

  • Targeted Therapies Drive Need For Flexible, Small-Volume Manufacturing
    Targeted Therapies Drive Need For Flexible, Small-Volume Manufacturing

    Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.

  • Route Scouting In API Development: A Luxury Or Necessity?
    Route Scouting In API Development: A Luxury Or Necessity?

    Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.

  • How To Rapidly Create Single-Use Biomanufacturing Capacity
    How To Rapidly Create Single-Use Biomanufacturing Capacity

    To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.

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OUTSOURCING EVENTS

24th Annual Validation Week October 22 - 24, 2018
San Diego, CA)
IRT 2018 October 22 - 23, 2018
Philadelphia, PA)
eCOA/ePRO 2018 October 23, 2018
Philadelphia, PA)
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